BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ProstatID

    Reg #: 3023522713 · FEI: 3023522713 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOT IMAGE, INC.
    Registration Number
    3023522713
    FEI Number
    3023522713
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14301 FNB Pkwy, Suite #109
    City
    Omaha
    State
    NE
    ZIP
    68154
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212783

    Owner / Operator

    Firm Name
    BOT IMAGE, INC.
    Operator Number
    10085779
    Address
    20 Sunset Shores Drive
    City
    Belgrade
    State
    ME
    Postal Code
    04917
    Country
    US
    Correspondent
    RANDALL W JONES

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ

    Proprietary Names

    ProstatID

    Establishment Types

    Manufacture Medical Device